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Adult Stem Cell Response to Burn Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00609661
Recruitment Status : Withdrawn (Assay for stem cell analysis not available)
First Posted : February 7, 2008
Last Update Posted : October 8, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is designed to determine the response of adult stems cells, also referred to as mesenchymal stem cells (MSCs), to tissue injury resulting from thermal burns. The study will consist of a one time collection of a patient's blood, about one teaspoon, on the third day following the initial burn. MSCs in the blood will then be quantitated and identified using according to unique proteins found on their cell surface using flow cytometry. The results of flow cytometry analysis will then be compared to the patients characteristics (age, sex, race, etc.), their past medical history (hx of diabetes, hypertension, heart disease, etc.) and to the patient outcome (length of hospital stay, mortality, etc.).

Condition or disease
Wound Healing Burn

Detailed Description:
Traumatic and non-traumatic disease processes result in varying tissue injury that can culminate in organ failure and death. Current literature has demonstrated that adult stem cells (ASCs) are mobilized into peripheral circulation as a heterogeneous population of cells following tissue injury. The significance of this heterogeneity has not yet been defined. Other studies have shown ASCs augment tissue repair under appropriate conditions. This proposal will begin to elucidate the mechanism of ASC activation, mobilization and localization to sites of injury. This study will use flow cytometry to identify subsets of ASCs mobilized in response to tissue injury and compare this response to the patient's demographics, comorbidities, in hospital morbidities, and mortality. Patients with thermal burns will be used as a model of tissue injury given the quantity of tissue injured and the robust signal generated from this injury. ASCs are currently being investigated as adjuncts to tissue repair involving a host of tissues, including cardiac, neural, and renal. The identification of a specific subset of ASCs selectively mobilized in response to tissue injury would alter all studies involving ASCs in tissue repair and necessitate the identification and targeting of subsets selectively mobilized in response to injury to each particular tissue.

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Burn Severity and Patient Outcomes to the Subsets of Mesenchymal Stem Cells Identified in the Blood of Burn Victims
Study Start Date : February 2008
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
Patients presenting to the Ohio State University Emergency Department or directly admitted to the Ohio State University Burn Unit following thermal burn.
2
Healthy volunteers


Outcome Measures

Biospecimen Retention:   Samples With DNA
Whole Blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any patient who is consented following presentation to the Ohio State University Emergency Department or directly admitted to the Ohio State University Burn Unit within three days of a thermal burn
Criteria

Inclusion Criteria:

  • Any consentable patient presenting to the Ohio State University Emergency Department or directly admitted to the Ohio State University Burn Unit within three days of a thermal burn

Exclusion Criteria:

  • Prisoners
  • Pregnant patients and nonconsentable patients.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00609661


Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Chandan K Sen, PhD Ohio State University
Study Director: Daniel P Zelinski, MD, PhD Ohio State University
Study Director: Sorabh Khandelwal, MD Ohio State University
More Information

Responsible Party: Chandan K Sen, Principal Investigator, Ohio State University
ClinicalTrials.gov Identifier: NCT00609661     History of Changes
Other Study ID Numbers: 2006H00286
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: October 8, 2012
Last Verified: October 2012

Keywords provided by Chandan K Sen, Ohio State University:
Mesenchymal Stem Cells, Burn

Additional relevant MeSH terms:
Burns
Wounds and Injuries